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A Research Study to Examine Cutaneous Allodynia and Cluster Headache

Completed
Conditions
Cluster Headache
Interventions
Other: There are no interventions in the observational study. The symptom of allodynia was measured.
Registration Number
NCT00329836
Lead Sponsor
Thomas Jefferson University
Brief Summary

This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
Inclusion Criteria
  • Male and female patients aged 18-75, inclusive
  • Diagnosis of cluster headache, episodic or chronic.
  • Patients with episodic CH can be either in active cluster period or not.
  • Ability to read and understand an informed consent form, where the study protocol is described.
Exclusion Criteria
  • Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
  • Patients who are cognitively impaired, as determined by investigator
  • Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
  • Patients who had taken an acute pain medication within 24 hours prior to allodynia testing.
  • Patients with skin diseases that may cause abnormal skin sensation.
  • Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing
  • Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Subjects with cluster headacheThere are no interventions in the observational study. The symptom of allodynia was measured.Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
Primary Outcome Measures
NameTimeMethod
Prevalence of Allodynia in Subjects With Cluster HeadacheAllodynia was assessed at the screening visit

Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Jefferson Headache Center/ Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

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